BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOPEN

    MDR report key: 391359 · Received May 1, 2002

    Report

    Report Number
    9681821-2002-00021
    Event Type
    Injury
    Date Received
    May 1, 2002
    Report Date
    April 6, 2002
    Manufacturer
    NOVO NORDISK A/S, MEDICAL SYSTEMS
    Product Code
    FMF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    HYPERGLYCAEMIA [HYPERGLYCAEMIA NOS]. CASE DESCRIPTION: A PHYSICIAN REPORTED THAT A PT WAS HOSPITALIZED DUE TO HYPERGLYCAEMIA, WHILE USING ACTRAPID PENFILL WITH A NOVAPEN 3 AND NOVOFINE 30G NEEDLES. IN 2002, THE PT'S DIABETIC TREATMENT WAS CHANGED TO ACTRAPID VIAL AND PT'S BLOOD GLUCOSE LEVELS NORMALIZED. FOLLOW-UP INFO REC'D IN 04/2002 AND 2 DAYS LATER. NARRATIVE HAS BEEN UPDATED. INFO ON ANALYSIS RESULT HAS BEEN REC'D ON 04/2002. INFO ON FURTHER SUSPECTED PRODUCTS (NOVOPEN 3 AND NOVOFINE 30G) REC'D ON 04/2002. COMMENT: THIS CASE IS LINKED TO CASE 215332.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVOPEN INSULIN DELIVERY DEVICE FMF NOVO NORDISK A/S, MEDICAL SYSTEMS NA KSCG562

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization